Telerehabilitation Versus Face-to-Face LSVT BIG in Individuals With Parkinson Disease

June 9, 2026 updated by: Bezmialem Vakif University

The Effects of Telerehabilitation and Face-to-Face LSVT BIG Method on Motor and Non-Motor Symptoms in Individuals With Parkinson Disease

This prospective, randomized controlled trial will enroll 40 individuals with idiopathic PD (Hoehn & Yahr stages 1-3, MoCA ≥21). Participants will be randomly assigned in a 1:1 ratio to either a telerehabilitation LSVT BIG group or a face-to-face LSVT BIG group, with randomization stratified by Hoehn & Yahr stage using a computer-based block randomization system. Both groups will receive the standard LSVT BIG® protocol consisting of 16 sessions over four weeks (4 days/week, 1 hour/session). Treatment content will include maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. The telerehabilitation group will receive all sessions via synchronous video conferencing under physiotherapist supervision, while the face-to-face group will receive sessions in a clinical setting. Both groups will be assigned home exercise programs in accordance with the LSVT BIG® protocol, and treatment adherence will be monitored throughout the study.

Outcomes will be assessed at baseline, after 4 weeks of treatment, and at 6-month follow-up. Primary outcomes include postural stability and fall risk assessed with the Biodex Balance System (anterior-posterior stability index, mediolateral stability index, general stability index, fall risk index, limits of stability) and motor and non-motor symptom severity assessed with the MDS-UPDRS (Parts I, II, and III). Secondary outcomes include dynamic balance (Mini-BESTest), functional mobility (Timed Up and Go Test, 10-Meter Walk Test), quality of life (PDQ-39), depression (Beck Depression Inventory), sleep quality (Parkinson's Disease Sleep Scale), fatigue (Parkinson Fatigue Scale), cognitive function (MoCA), and treatment satisfaction (Global Rating of Change Scale).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson's disease
  • Hoehn and Yahr stage 1-3
  • Montreal Cognitive Assessment (MoCA) score ≥ 21
  • Ability to use a smartphone, tablet, or computer
  • Access to internet connection and basic digital literacy
  • Participation in activities outside the home at least 3 days per week

Exclusion Criteria:

  • Diagnosis of a neurological condition other than idiopathic Parkinson's disease
  • Change in antiparkinsonian medication regimen during the study period
  • History of deep brain stimulation
  • Visual or hearing impairment that would prevent participation in treatment or assessments
  • Severe cardiovascular, orthopedic, pulmonary, or systemic comorbidity contraindicating exercise
  • Diagnosis of severe depression, psychotic disorder, or uncontrolled psychiatric illness
  • Participation in another structured physiotherapy or rehabilitation program for
  • Parkinson's disease within the last three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Face-to-Face LSVT BIG
Participants will receive the standard LSVT BIG® protocol delivered in a clinical setting. The protocol consists of 16 sessions over four weeks (4 days/week, 1 hour/session), including maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. Home exercise assignments will be provided in accordance with the standard LSVT BIG® protocol.
Other: Face-to-Face LSVT BIG
The standard LSVT BIG® protocol will be delivered in a clinical setting by a certified physiotherapist. The protocol consists of 16 sessions over four weeks (4 days/week, 1 hour/session). Treatment content includes maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. Home exercises will be assigned on treatment days (once) and non-treatment days (twice daily) in accordance with the standard LSVT BIG® protocol.
Active Comparator: Telerehabilitation LSVT BIG
Participants will receive the standard LSVT BIG® protocol delivered via synchronous video conferencing under physiotherapist supervision. The protocol consists of 16 sessions over four weeks (4 days/week, 1 hour/session), including maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. Home exercise assignments will be provided in accordance with the standard LSVT BIG® protocol.
Other: Telerehabilitation LSVT BIG
The standard LSVT BIG® protocol will be delivered via synchronous video conferencing under physiotherapist supervision. The protocol consists of 16 sessions over four weeks (4 days/week, 1 hour/session). Treatment content includes maximal daily exercises, functional component tasks, "big" gait training, and individually tailored hierarchy tasks. Home exercises will be assigned on treatment days (once) and non-treatment days (twice daily) in accordance with the standard LSVT BIG® protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biodex Balance System
Time Frame: Baseline, Week 4, Month 6
Baseline, Week 4, Month 6
Movement Disorder Society-Unified Parkinson's Disease Rating Scale
Time Frame: Baseline, Week 4, Month 6
Motor and non-motor symptom severity will be assessed using Parts I, II, and III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale. Part I evaluates non-motor symptoms, Part II evaluates motor aspects of daily living, and Part III evaluates clinician-rated motor signs. Each item is scored from 0 (normal) to 4 (severe), with higher total scores indicating greater symptom severity.
Baseline, Week 4, Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mini-Balance Evaluation Systems Test
Time Frame: Baseline, Week 4, Month 6
Dynamic balance will be assessed using the 14-item Mini-Balance Evaluation Systems Test, evaluating postural responses, anticipatory postural adjustments, dynamic gait, and sensory orientation. Each item is scored from 0 to 2, with a maximum total score of 28. Higher scores indicate better balance performance.
Baseline, Week 4, Month 6
Timed Up and Go Test
Time Frame: Baseline, Week 4, Month 6
Functional mobility and dynamic balance will be assessed by measuring the time (in seconds) required to rise from a chair, walk 3 meters, turn, and return to sitting. Longer completion times indicate poorer functional mobility.
Baseline, Week 4, Month 6
Parkinson's Disease Questionnaire-39
Time Frame: Baseline, Week 4, Month 6
Health-related quality of life will be assessed using the 39-item Parkinson's Disease Questionnaire-39, covering 8 domains. Each item is scored from 0 to 4, with domain scores ranging from 0 to 100. Higher scores indicate worse quality of life.
Baseline, Week 4, Month 6
Beck Depression Inventory
Time Frame: Baseline, Week 4, Month 6
Depressive symptoms will be assessed using the 21-item Beck Depression Inventory. Each item is scored from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms.
Baseline, Week 4, Month 6
Parkinson's Disease Sleep Scale
Time Frame: Baseline, Week 4, Month 6
Sleep quality and sleep-related disturbances will be assessed using the 15-item Parkinson's Disease Sleep Scale. Each item is scored on a visual analog scale from 0 to 10. Lower total scores indicate poorer sleep quality.
Baseline, Week 4, Month 6
Parkinson Fatigue Scale
Time Frame: Baseline, Week 4, Month 6
Fatigue severity and its impact on daily functioning will be assessed using the 16-item Parkinson Fatigue Scale. Each item is scored from 1 to 5, with higher total scores indicating greater fatigue.
Baseline, Week 4, Month 6
Montreal Cognitive Assessment
Time Frame: Baseline, Week 4, Month 6
Cognitive function will be assessed using the Montreal Cognitive Assessment, evaluating attention, executive functions, memory, language, visuospatial skills, abstract thinking, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
Baseline, Week 4, Month 6
Global Rating of Change Scale
Time Frame: Week 4, Month 6
Patient-perceived change in overall condition will be assessed using the Global Rating of Change Scale. Scores range from -2 (much worse) to +2 (much better), with higher scores indicating greater perceived improvement.
Week 4, Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bezmialem Vakif University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul University - Cerrahpasa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-83460662-050.04-1593414

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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